On the last 12th September, Decree-Law No. 162/2016 approved a set of measures applicable to the community pharmacies, whose principle aim is to promote the rational use and access by the patients to the medicinal products and to the therapies in general.
The measures approved were the following:
(i) The possibility of the community pharmacies to provide interventional services for public health;
(ii) The set of limits to the discounts granted by the pharmacies in the sale of the medicinal products;
(iii) The attribution of a compensation by the Government to the community pharmacies for the dispense of the reimbursed medicinal products inserted into homogeneous groups.
The provision of the interventional services for public health includes the collaboration of the pharmacies and of integrated programmes with the primary healthcare services, the collaboration on the evaluation of the healthcare technologies, the needles exchange, the control of the patients joining to the therapeutic and dispense of the medicines currently granted by the hospital pharmacies. Notwithstanding the fact that the law already includes these services, it is expected to be published an Order of the Ministry of Health, describing the terms and conditions applicable to the contracting of these services. This Order will also define dependent forms of remuneration based on the added value that will result from the assessment of the service delivery.
The measures that will apply to the limits imposed to the discounts granted by the pharmacies in the sale of the medicinal products will be based upon public health grounds, the sustainability of the sector and the competition protection, but shall also be defined by Dispatch of the Ministry of Health. We will have to wait for the publish of this dispatch in order to evaluate the type and impact of the measures in question.
Last, but certainly not the least, it was approved (once again) one measure to compensate the pharmacies for the sale of the generic medicinal products, as a way to promote the “rational use and more cost-effective” of the medicinal products. This measure, already regulated by Order No. 262/2016, of 7th October, establishes the payment to the pharmacy communities of a specific remuneration linked to their contribution in reducing the retail price of the medicinal products inserted into homogeneous groups. More specifically, the pharmacies have the right to receive from the Nation Health Service, 0,35 € Euros (thirty- five cents) for each package of medication distributed with price less than or equal to the 4 th lowest price of the homogeneous group.
In fact, this measure has the same purpose of the measure approved to enter into force in 2015, that established the payment of an additional contribution to the community pharmacies for the distribution of generic medicinal products reimbursed by the State. The principle aim of such measure was also to promote the increase of the sale of the generic medicinal products in the market.
Although in practice (as happened in 2015), the amounts of the compensations were not very significant, it is a fact that these type of measures, under which are granted benefits to the pharmacies for the distribution of generic medicinal products, may violate specific rules established in the legal regime applicable to the medicinal products, as well as specific rules and principles of competition law.
In fact, the rules applicable to the adverting of the medicinal products are sustained upon the etic ground that the prescription, sale and consumption of medication shall be exclusively guided for health imperative grounds. In this sense, according with the rules established in the legal regime applicable to the medicinal products, the commercial practices that may be deemed as promotional of the consumption of prescription-only medicinal products are expressly forbidden, namely the offer of benefits in kind. In this respect, the benefit granted to the pharmacies communities may be considered as a promotional act for the sale of the generic medicinal products.
Finally, it is important to mention that the implementation of this measure, which foresees the payment to the pharmacies communities of a compensation, will enter into force on 1st January 2017.